EU SECTION??? Into the unknown Should we be afraid of nanotechnology? DG SANCO’s Vladimir Garkov, Laurent Bontoux and Philippe Martin consider what is needed to continue making advances while building public trust in the area… T he products of nanotechnology are increasingly present on the consumer market (eg. healthcare, electronics, cosmetics, clothes), as well as in industrial (eg. information technology, coatings, energy technologies, automotive) and in medical applications (diagnostics, targeted drugs, and regenerative medicine). For example, nanoparticles are now being used in the manufacture of scratchproof eyeglasses, crack-resistant paints, anti-graffiti coatings for walls, transparent sunscreens, stain- and odour-repellent fabrics, fillers in tyres, food packaging, self-cleaning windows, and ceramic coatings for solar cells. As the number of nano-applications grows, the first signs of public anxiety have appeared. The Roman historian Titus Livius said that “we fear things in proportion of our ignorance of them.” Understanding the nature of nanotechnology and how to deal with it might help us overcome our natural, very human phobia of the unknown. ‘ Consumer trust and acceptance of emerging technologies such as nanotechnology are essential for the development of new consumer products and their market uptake. ’ According to the latest available Eurobarometer survey, Europeans do not perceive nanotechnology as risky; rather, they support its development, perceive it as being useful to society and morally acceptable. Moreover, Europeans have far greater confidence in regulation than their US or Canadian counterparts. For good reason. A US investigation found that EU member states invested nearly twice as much as the United States in research on the potential environment, health and safety hazards of nanotechnologies. A study published in ‘Nature Nanotechnology’ in September 2009 showed that nearly half of the people surveyed were not familiar with nanotechnology, yet this was not strongly associated with risk aversion. There is, 1 Public Service Review: European Union: issue 19 therefore, an opportunity for building public trust in nanotechnology. What is nanotechnology? Whereas science is concerned with understanding the way the world operates, technology emphasises the development of something practical. Technology is often defined as ‘applied science’. Like any other technology, nanotechnology is the invention of new processes and products with which we can improve quality of life. A nanometre is one-billionth of a metre and around 1,000th of the width of a human hair. Nanotechnology refers to manufacturing and engineering techniques applied at nanoscale – the scale of atoms and molecules. When particles get that small, they can acquire novel properties. Understanding these properties is essential for assessing the potential health and environmental risks, and for developing ways to address them. A safe and responsible development of nanotechnology Manufacturers and policy-makers alike are keen to ensure the introduction of nanotechnology based on public trust. In its 2004 Nanotechnology Strategy, the EU called for an ‘integrated, safe and responsible’ approach to the use of nanotechnologies. Consumer trust and acceptance of emerging technologies such as nanotechnology are essential for the development of new consumer products and their market uptake. There are other factors, though, that influence consumer acceptance of new technologies, such as the perception of risk-benefit ratios or communication of uncertainty. In light of the crucial significance of scientific knowledge for the safe and responsible development of nanotechnology, the European Commission has called on the independent scientific committees of the European Union, starting as early as 2003, to address some of the critical issues relevant to the assessment of the safety of nanomaterials. As a result, several opinions were adopted by the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR), by the Scientific Committee on Consumer Safety (SCCS) and its predecessor the Scientific Committee on Consumer Products (SCCP), and by the BIOHAZ Panel of the European Food Safety Authority (EFSA). SECTION??? The importance of nanotechnology – a European Commission perspective February saw Ireland’s Máire Geoghegan-Quinn sworn in as European Commissioner for Research, Innovation and Science, taking over from Janez Potoc̆nik of Slovenia, who had held the post since 2004. Potocnik oversaw a time of massive change in science and research during his tenure, with the global community moving beyond the ICT revolution of the 1990s to the green revolution in the latter part of the last decade. And as early as 2005, Potoc̆nik highlighted in his action plan for nano-research the importance of nanotechnology science, which he predicted would be at the heart of European research for decades to come. He stated: “Nanotechnology is one of the most promising scientific fields. I would compare it to the impact of ICT or biotechnology. Why? Because if you have one breakthrough in nanotechnology you can use it across sectors. And that’s why everybody, including Europe, is working hard in the nanotechnology area. “We see it as one of the most promising areas of research which could very much influence our quality of life, and influence global competitiveness.” It is a sentiment that can be seen to straddle Potoc̆nik’s tenure being as it is at the core of the last major policy initiative he made as EU Commissioner. In July 2009, Potoc̆nik announced three major public private partnership opportunities for the private sector to work with scientists across the European Union to develop Nanomaterials and nanoparticles Nanoparticles are incidentally produced by natural phenomena like volcanoes, and by human industrial and domestic processes such as cooking, and the use of internal combustion and jet engines in our cars and planes, which release huge numbers of nanoparticles into the atmosphere. Nanomaterials that are engineered to narrow specifications are novel. investigation found that ‘ AEUUSmember states invested nearly twice as much as the United States in research on the potential environment, health and safety hazards of nanotechnologies. ’ Two types of nanostructures are usually considered when dealing with the potential adverse health risks of nanotechnology products: free nanoparticles and larger objects containing nanostructures. The scientific committees consider that it is persistent-free nanoparticles and their aggregation into larger objects containing nanopores, giving them a very large surface area, that green technologies that will maintain Europe’s position at the forefront of modern science thinking and application. Speaking at a conference in Brussels, Potoc̆nik highlighted the role PPPs could play in developing the sustainability agenda for future generations when he announced EU funds for the development of three major facets of research: ‘Green Cars’, ‘Factories of the Future’ and ‘Energy-Efficient Buildings’. The money available, especially at a time of global financial uncertainty, is impressive: €1.2bn earmarked for research and development as part of the Factories for the Future programme; €1bn dedicated to researching energy-efficient buildings; and another €5bn made available for research on the Green Car Initiative. Constant throughout the development of policy that ended with the announcement of the PPP projects, was Potoc̆nik’s belief that clean technologies, biotechnology and nanotechnology would be as crucial for the future European economy as ICT was in the 1990s. He argued: “The EU must not miss this opportunity. We have to be the champion of the third industrial revolution; the green revolution.” Máire Geoghegan-Quinn now has the responsibility of taking forward the scientific agenda for the European Union. It is clear, given her predecessor’s strong record, that nanotechnology will remain at the forefront of European science and research. It is a policy that could see the European Union lead the world in scientific innovation. require the most attention. The higher surface to volume ratio is perhaps the single most important characteristic of the products of nanotechnologies. Exposure to nanoparticles So far, inhalation is considered to be the main route of human exposure to nanoparticles in view of how easily they can become suspended in air. This is clearly the case for the nanoparticles from non-intentional sources. Furthermore, nanoparticles undergo numerous changes both in the environment and in the human body that affect their impact and fate. Some of those changes are summarised in Fig 1. After deposition in the lungs, a fraction of the nanoparticles may be translocated to other organs such as the liver, spleen and possibly to the foetus in pregnant women. There is also evidence that nanoparticles from diesel exhaust entering the nose can reach the brain. The rapidly increasing use of manufactured nanoparticles in consumer products, in particular cosmetics, is likely to increase human exposure through skin and ingestion. The release and dissemination of nanoparticles may occur through air, water and soil, thus exposing species living in any environment. Public Service Review: European Union: issue 19 2 SECTION??? Fig. 1: The potential changes in nature of a nanomaterial due to the surrounding media Measuring the nano-hazard In order to be able to assess potential risks of nanoparticle exposure, it is necessary to understand the relationship between the dose of exposure and its potential effects. There is knowledge and methods on how to do this for the large number of chemicals in use. The question is whether these methods developed for chemicals in general are applicable to nanoparticles. ‘ Regulators must control that what industry says is true. Scientists must develop the methods and knowledge to be used by industry. Regulators and consumers must remain critical but open-minded to be able to reap the benefits from nanotechnology. ’ The SCENIHR considers that, in general, existing methodologies are likely to identify the hazards linked to the use of nanoparticles, even though they exhibit different properties than the same material without nanoscale features. However, validation of these methodologies for testing nanoparticles is still needed and modifications in current methodologies will probably be necessary to improve their accuracy and applicability to nanoparticles. Work to that end has already started, in particular under the auspices of the OECD. Given the indications that nanoparticles could migrate from the lungs to other organs, the SCENIHR emphasises the need to develop 3 Public Service Review: European Union: issue 19 quantitative assays that could determine the presence of nanoparticles in different tissues of the human body. The dose, a singular case by case issue One particular issue linked to nanoparticles is how to characterise the dose. For standard substances, expressing the dose as a mass of substance per unit mass or unit volume is sufficient. For nanoparticles, several parameters are needed to describe the dose and those that are most significant can be different in different situations, depending on the type of material, the type of test matrix or other conditions. The SCENIHR has also recognised that the behaviour of nanomaterials and their biological effects is largely determined by what adheres to their surface. Therefore, for risk assessment, good knowledge of their intentional and unintentional coatings is necessary besides a full characterisation of the ‘raw’ nanomaterial. For all those reasons, the scientific committees recommend a case by case approach to the assessment of potential risks linked to nanomaterials. In view of the dearth of data and of the work still needed on methodology, assessing the numerous nanomaterials coming out of technological development will take a long time. Current scenarios What is, then, the certainty that the products of nanotechnology are safe? Manufacturers have a legal obligation to ensure that the products they put on the market are safe, but how can we control this safety, and reassure the public? SECTION??? Three cases emerge: ■ Industry is transparent about its use of nanotechnologies. In this case, either the applications are non-controversial (eg. miniaturisation of computer chips, development of novel materials, nanomedicine) or they are (eg. nano-size food supplements, nanosilver in socks); ■ ■ Industry puts products on the market that contain engineered nanomaterials but does not advertise it; Industry claims that it does not put products on the market that contain engineered nanomaterials but is suspected by consumers of doing so. In the first case, controversial applications can be easily identified and assessed case by case. In the other two, the lack of credible information about which products contain nanomaterials, and the safety testing done on them, has led to speculation and fears that industry is hiding information about potentially negative impacts. The challenge is to bring more transparency so as to build trust among stakeholders. The 3rd Nano Safety for Success Dialogue conference, organised by the Directorate-General Health and Consumers last November, was a small step in this direction. On that occasion, industry representatives spoke about four ‘nano-products’ currently on the market: TiO2 in sunscreens/cosmetics; nanoparticles in paint; carbon nanotubes in paints and materials; and nanosilver in textiles. Those who were most open elicited the most questions, but also generated the most trust amongst stakeholders. The event concluded with a call for a series of small-scale focused conversations. Critical period To complicate matters, some scientific studies are hyped in the media, with headlines like one in ‘Popular Science’ recently: ‘China Reports the First Human Nano-Fatalities.’ In the age of instant and constant information, it is difficult to communicate credible information on controversial and emerging issues with the potential to ‘go viral’. If repeated enough, false perceptions may hold even if the reported information is inaccurate. We have reached a critical time window, which makes or breaks nanotechnology. Now is the time for building public trust. This requires efforts from all parties: industry, regulators, scientists and consumers. Industry must demonstrate the safety of its products. Regulators must control that what industry says is true. Scientists must develop the methods and knowledge to be used by industry. Regulators and consumers must remain critical but open-minded to be able to reap the benefits from nanotechnology. Minimising risks and building trust ■ Easily available information about the nano-products on the market; ■ Understanding of the risk assessment process and of the uncertainty associated with it; ■ Involvement of civil society in policy-making through open dialogue and analysis of the risks and benefits of nanotechnology. The European Commission has been at the forefront of tackling these issues. In addition to launching a strategy in 2004 and an Action Plan in 2005, it was at the origin of the work by the independent scientific committees. It launched the Nano Safety for Success Dialogues, commissioned studies on the market availability of nanoproducts and prepared a review of how EU legislation is equipped to deal with nanotechnology (Commission ‘Communication on regulatory aspects of nanomaterials’, 17th June 2008). This review concluded that overall, the current EU legislative framework ‘covers in principle the potential health, safety and environmental risks in relation to nanomaterials.’ However, it added that ‘current legislation may have to be modified in the light of new information becoming available, for example, as regards thresholds used in some legislation.’ Commission initiatives have triggered responses from the European Parliament, which called for further reviews of all relevant legislation and for the implementation of the principle ‘no data, no market’ for all applications of nanomaterials in consumer products. In conclusion, the science-based approach to risk assessment and to policy-making, combined with a continuous dialogue with the public, is crucial for building trust in nanotechnology. Vladimir Garkov Scientific Committee Management Officer Tel: +32 2 29 66 559 [email protected] Laurent Bontoux Principal Administrator [email protected] Philippe Martin Principal Administrator [email protected] Directorate General for Health and Consumers (DG SANCO) European Commission http://ec.europa.eu/dgs/health_ consumer/index_en.htm Consumer confidence and public trust in nanotechnology depend on several interconnected elements: Public Service Review: European Union: issue 19 4
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